Key Developments For Abraxis Bioscience, Inc.
Abraxis Bioscience, Inc. (ABII.O) (Nasdaq)
Abraxis BioScience, Inc.'s ABRAXANE Receives Orphan Drug Status For Treatment of Pancreatic Cancer And Stage IIB-IV Melanoma
Abraxis BioScience, Inc. announced that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation to the chemotherapy agent ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of pancreatic cancer as well as stage IIB-IV melanoma. Pancreatic cancer and metastatic melanoma can be particularly hard to treat cancers.
Abraxis BioScience, Inc. Announces Results from Phase 2 Study of ABRAXANE In Combination With Carboplatin
Abraxis BioScience, Inc. announced that the results of a phase 2 study were presented at the 13th Annual World Conference on Lung Cancer of the International Association for the Study of Lung Cancer (IASLC) in San Francisco, CA. The data presented provided evidence of anti tumor activity in patients with advanced non small cell lung cancer (NSCLC) receiving first line treatment regimens of albumin bound nab paclitaxel (ABRAXANE for Injectable Suspension) in combination with carboplatin. Clinical activity and safety indicators from this study led to the selection of weekly 100 mg/m2 ABRAXANE as an optimal dose. A Phase 3 randomized, multicenter study comparing carboplatin in combination with weekly 100 mg/m2 ABRAXANE or Taxol injection is ongoing. The results from this phase 2 study show clinical activity that could offer promise in the treatment of this hard to treat cancer. Data from this phase 2 investigation across multiple dose and administration schedules of ABRAXANE led to the decision to initiate a phase 3 trial to further study ABRAXANE for the treatment of NSCLC. The Phase 3 trial is ongoing and includes 1,050 patients from 111 sites globally.
Abraxis BioScience, Inc. Appoints Rick Rodgers Chief Financial Officer
Abraxis BioScience, Inc. announced the appointment of Rick Rodgers as Senior Vice President and Chief Financial Officer, succeeding David O`Toole.
Abraxis BioScience, Inc. Receives Approval For Advanced Breast Cancer Patient Treatment in Quebec
Abraxis BioScience, Inc. announced the listing of ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg in Quebec for the treatment of metastatic breast cancer with a recommendation from the Quebec Conseil du Médicament and approval from the Quebec Ministry of Health. ABRAXANE is approved and commercially available in Canada for the treatment of metastatic breast cancer, including first-line disease. The listing of ABRAXANE in Quebec offers an important new treatment option to Quebec women with advanced breast cancer.
Abraxis BioScience, Inc. Announces Potential Benefit of Nab Paclitaxel In Combination With Bevacizumab For First Line Treatment of Metastatic Breast Cancer
Abraxis BioScience, Inc. announced the results from a new ongoing study demonstrating anti tumor activity for three dosing regimens of nab paclitaxel (ABRAXANE for Injectable Suspension) (paclitaxel protein bound particles for injectable suspension) (albumin bound) given in combination with bevacizumab in the first line treatment of patients with metastatic breast cancer. The overall response rate for patients receiving a combination of weekly nab paclitaxel (130 mg/m2) with twice weekly bevacizumab (10 mg/kg) was 46%. Patients who received a combination of nab paclitaxel (260 mg/m2) with bevacizumab (10 mg/kg) plus filgrastim administered every two weeks and patients who received nab paclitaxel (260 mg/m2) with bevacizumab (15 mg/kg) administered every three weeks had overall response rates of 39% and 44%, respectively. The safety profile was generally consistent with the known safety of nab paclitaxel and of bevacizumab, although sensory neuropathy was limiting in the weekly nab paclitaxel dosing arm suggesting a three week on treatment, one week off treatment regimen may be preferable. Results also demonstrated a prolonged time to progression (9.0 months) among patients who received weekly nab paclitaxel, compared to the every two and three week dosing regimens (6.3 months and 7.7 months, respectively). Overall survival data has not yet been established, and is currently being evaluated.
